US20190116924A1 - Medical shoe having a plurality of outsole projections - Google Patents

Abstract

A medical shoe having a plurality of outsole projections is provided. The medical shoe may include a sole assembly configured to support a foot, and a frame surrounding the sole assembly. The sole assembly may include a midsole portion forming a substantially planar surface for supporting the foot and an outsole portion including the plurality of outsole projections extending from the midsole portion. The frame may include a plurality of through holes corresponding to the plurality of outsole projections. The plurality of outsole projections may extend through the plurality of through holes so as to form a ground contacting surface. The plurality of outsole projections may also be provided in a symmetrical pattern. The sole assembly may be secured to the frame by a self-locking fit between the sole assembly and the frame.

Description

BACKGROUND1. Field
• Apparatuses and methods consistent with the present disclosure relate to a medical shoe for supporting a post-operative or otherwise traumatized patient's foot, and more particularly to a surgical shoe having a plurality of outsole projections configured to provide a customized weight distribution across a patient's foot. For example, the outsole projections may be configured to offload pressure at a location of a wound or other traumatized area of the patient's foot.
2. Description of the Related Art
• Medical shoes play an essential role in recovery following surgery or other trauma to a patient's foot. For instance, the medical shoe may assist in redistributing weight away from the wound or traumatized area, such that the wound or traumatized area may heal.
• However, such medical shoes may be prohibitively expensive, as they often require labor intensive manufacturing steps including gluing and stitching. Additionally, these manufacturing steps are often susceptible to failure, and frequently result in shortening the usable life of the medical shoe.
• As a result, there are no suitable post-trauma medical shoes that effectively redistribute weight away from a wound or traumatized area of a patient's foot without requiring labor intensive manufacturing methods including gluing and stitching to assemble the medical shoe.
• There is therefore a need to provide a post-trauma medical shoe that does not require labor intensive and failure prone manufacturing methods including gluing and/or stitching (or minimizes the same), designed to be used by patients who have experienced either surgery of the foot, trauma to the foot, or have foot pain aggravated by weight bearing such as heel spur syndrome, plantar fascitis, calcinosis, Achilles tendonitis, or have skin lesions, ulcers or infections of the foot area where reduction of weight would enhance the healing process and allow the patient to be ambulatory.
SUMMARY
• According to one aspect of an exemplary embodiment, a medical shoe includes a sole assembly configured to support a foot, the sole assembly including: a midsole portion forming a substantially planar surface for supporting the foot; and an outsole portion comprising a plurality of outsole projections extending from the midsole portion; and a frame surrounding the sole assembly, the frame including a plurality of through holes corresponding to the plurality of outsole projections. The plurality of outsole projections may extend through the plurality of through holes in the frame so as to form a ground contacting surface. The plurality of outsole projections may be provided in a symmetrical pattern. The sole assembly may be secured to the frame by a self-locking fit between the sole assembly and the frame.
• The sole assembly may further include a sole assembly lip portion extending around a circumferential edge of the sole assembly in a direction perpendicular to the substantially planar surface. The frame may further include a frame lip portion surrounding the sole assembly lip portion such that a contour of an inner surface the frame lip portion corresponds to a contour of an outer surface the sole assembly lip portion. The self-locking fit may include a frictional force between the sole assembly and the frame.
• The sole assembly may further include a fixation projection extending from the sole assembly lip portion in a direction parallel to the substantially planar surface. The frame may further include a fixation projection through hole in the frame lip portion. The fixation projection may extend into the fixation projection through hole.
• The midsole portion may include a rear heel portion, a midfoot portion, and a front forefoot portion; and the plurality of outsole projections may include: a plurality of outsole forefoot projections extending from the front forefoot portion; a plurality of outsole midfoot projections extending from the midfoot portion, and an outsole heel projection extending from the rear heel portion.
• A thickness of at least one of the plurality of outsole midfoot projections may be greater than a thickness of the outsole heel projection. A thickness of at least one of the plurality of outsole midfoot projections may be greater than a thickness of at least one of the plurality of outsole forefoot projections.
• The sole assembly may be composed of ethylene-vinyl acetate. The plurality of outsole projections may have a non-uniform density.
• The medical shoe may further include a removable cover secured to the frame and located above the sole assembly, such that a cavity configured to surround the foot is defined by a bottom surface of the removable cover and a top surface of the sole assembly. The removable cover may include ventilation holes.
• The medical shoe may further include a fixation element and a closure strap. The fixation element may be secured to a fixation projection extending from the frame. The fixation element may include a fixation element slot configured to receive the closure strap. The removable cover may include a removable cover slot configured to receive the closure strap. The closure strap may be positioned through the fixation element slot and through the removable cover slot.
• The medical shoe may further include a removable insole located on the substantially planar surface. The removable insole may include a foot supporting portion; and a plurality of pressure distribution pegs extending from the food supporting portion towards the substantially planar surface. The plurality of pressure distribution pegs may be non-uniform in height.
• According to an aspect of an exemplary embodiment, a snap fit medical shoe assembly includes a sole assembly configured to support a foot, the sole assembly including: a midsole portion forming a substantially planar surface for supporting the foot; an outsole portion comprising a plurality of outsole projections extending from the midsole portion; and a sole assembly lip portion extending around a circumferential edge of the sole assembly in a direction perpendicular to the substantially planar surface; a rigid exoskeleton configured to surround the sole assembly, the rigid exoskeleton including a plurality of through holes corresponding to the plurality of outsole projections and an exoskeleton lip portion corresponding to the sole assembly lip portion; and a removable cover configured to be secured to the rigid exoskeleton. The plurality of outsole projections may be configured to extend through the plurality of through holes in the rigid exoskeleton so as to form a ground contacting surface. A contour of an inner surface the exoskeleton lip portion may correspond to a contour of an outer surface the sole assembly lip portion, such that the sole assembly is configured to be secured to the rigid exoskeleton by a snap fit between the sole assembly and the rigid exoskeleton.
• The midsole portion may include a rear heel portion, a midfoot portion, and a front forefoot portion. The plurality of outsole projections may include a pair of outsole midfoot projections extending from the midfoot portion, and only one of: an outsole heel projection extending from the rear heel portion; or a pair of outsole forefoot projections extending from the front forefoot portion. The plurality of outsole projections may be provided in a symmetrical pattern.
• The plurality of outsole projections may include the pair of outsole forefoot projections extending from the front forefoot portion. The pair of outsole forefoot projections may be provided at an angle with respect to the substantially planar surface.
• The plurality of outsole projections may include a total of 7 outsole projections.
• According to an aspect of an exemplary embodiment, a method of attaching orthopedic bracing includes: providing a sole assembly configured to support a foot of a patient, the sole assembly including: a midsole portion forming a substantially planar surface for supporting the foot; and an outsole portion comprising a plurality of outsole projections extending from the midsole portion; providing a rigid exoskeleton, the rigid exoskeleton including a plurality of through holes corresponding to the plurality of outsole projections; positioning the sole assembly into an interior of the rigid exoskeleton such that the plurality of outsole projections extend through the plurality of through holes in the rigid exoskeleton, the plurality of outsole projections forming a ground contacting surface, such that the sole assembly is secured to the rigid exoskeleton by a snap fit between the sole assembly and the rigid exoskeleton; positioning the substantially planar surface adjacent to a bottom portion of the foot of the patient; and positioning a removable cover adjacent to a top portion of the foot of the patient and securing the removable cover to the rigid exoskeleton. The plurality of outsole projections may be provided in a symmetrical pattern.
• The providing the sole assembly may include providing a sole assembly based on data of the foot of the patient, such that the plurality of outsole projections are oriented according to a medical condition of the patient.
• The providing the rigid exoskeleton may include providing a rigid exoskeleton not based on the data of the foot of the patient.
• The medical condition of the patient may be one from among: surgery of the foot, trauma of the foot, a wound of the foot, and an ulceration of the foot.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and/or other aspects will become apparent and more readily appreciated from the following description of the exemplary embodiments, taken in conjunction with the accompanying drawings, in which:
• FIG. 1 is a side view of a medical shoe according to an aspect of an exemplary embodiment;
• FIG. 2 is an exploded side elevation view of a medical shoe according to an aspect of an exemplary embodiment;
• FIG. 3 is a side elevation view of a frame according to an aspect of an exemplary embodiment;
• FIGS. 4A, 4B, and 4C are bottom, side, and side elevation views of a sole assembly according to an aspect of an exemplary embodiment;
• FIGS. 5A and 5B are front and back perspective views of a fixation element according to an aspect of an exemplary embodiment;
• FIG. 6 is a side elevation view of a removable cover according to an aspect of an exemplary embodiment;
• FIG. 7 is a side perspective view of a liner according to an exemplary embodiment;
• FIG. 8 is a side perspective view of a medical shoe having a modified outsole heel projection according to an aspect of an exemplary embodiment;
• FIG. 9 is a side perspective view of a medical shoe having modified outsole forefoot projections according to an aspect of an exemplary embodiment;
• FIGS. 10A and 10B are front and back perspective views of a removable insole according to an aspect of an exemplary embodiment;
• FIG. 11 is a side perspective view of an ankle liner according to an aspect of an exemplary embodiment;
• FIGS. 12A and 12B are front and back perspective views of a removable toe cover according to an aspect of an exemplary embodiment; and
• FIG. 13 is a side perspective view of a medical shoe having a removable toe protector according to an aspect of an exemplary embodiment.
DETAILED DESCRIPTION
• Merits and features of the present disclosure, and a method for accomplishing the merits and features, will become apparent upon reference to the exemplary embodiments described below with the accompanying drawings. However, the present disclosure may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the disclosure to those of ordinary skill in the art. The scope of the disclosure is defined only by the claims.
• FIG. 1 is a side view of a medical shoe according to an aspect of an exemplary embodiment.FIG. 2 is an exploded side elevation view of a medical shoe according to an aspect of an exemplary embodiment.
• A medical shoe2 according to an aspect of an exemplary embodiment includes aframe4, asole assembly6, and aremovable cover12. Theframe4,sole assembly6, andremovable cover12 are separable from each other, and are not integrally formed with one another.
• Theframe4 is made of a lightweight material and acts as a rigid exoskeleton outside thesole assembly6. For instance, theframe4 has a concave interior portion configured to receive thesole assembly6 so that thesole assembly6 may be inserted intoframe4. Oncesole assembly6 is inserted into theframe4, theframe4 surrounds an exterior circumference of thesole assembly6, for instance to form a protective barrier around thesole assembly6.
• Thesole assembly6 is an insert for inserting into theframe4 and includes amidsole portion8 and an outsole portion10 (seeFIG. 2) that are integrally formed with one another. In other words, thesole assembly6 may be a single piece comprising themidsole portion8 and theoutsole portion10. Themidsole portion8 defines a top portion of thesole assembly6 and includes a foot bed area for contacting and/or supporting a patient's foot. Themidsole portion8 is received into and is surrounded by theframe4.
• Theoutsole portion10 defines a bottom portion of thesole assembly6 and extends from a bottom surface of themidsole portion8. Theoutsole portion10 is made up of a plurality of outsole projections that, in use, form the ground contacting surface of thesole assembly6.
• Theframe4 and thesole assembly6 are configured to establish a self-locking fit, for instance a snap fit, when thesole assembly6 is inserted into theframe4. For instance, as discussed in more detail below, the peripheral shape of thesole assembly6 may correspond to the peripheral shape of theframe4 such that thesole assembly6 is received into theframe4 and the self-locking fit can be established. Additionally, or in the alternative, projection portions of theoutsole portion10 may be fit into corresponding holes in theframe4 to reinforce and secure the self-locking fit between thesole assembly6 and theframe4. Once the self-locking fit is engaged between theframe4 and the sole assembly6 (for instance, as in the configuration shown inFIG. 1), the self-locking fit can be disengaged by separating thesole assembly6 from theframe4. This can be done by force, for instance by pulling theframe4 and thesole assembly6 in opposite directions.
• Theframe4 and thesole assembly6 may be fully self-locking, such that glue and stitching is not required. In other words, theframe4 and thesole assembly6 can be secured without gluing or stitching, and the self-locking fit may be sufficient to secure theframe4 to thesole assembly6 for use by a patient. Once the self-locking fit between theframe4 and thesole assembly6 is established, a force of friction between theframe4 and thesole assembly6 holds theframe4 and thesole assembly6 in mutual contact.
• As will be discussed later, additional features may be provided to maintain the self-locking fit between theframe4 and thesole assembly6. For instance, thesole assembly6 may include a projection extending from themidsole portion8 in a substantially horizontal direction. The projection may be received into a corresponding through hole in theframe4 in order to establish or maintain the self-locking fit between theframe4 and thesole assembly6.
• As shown inFIG. 2, theremovable cover12 forms a top portion of the medical shoe2. Theremovable cover12 is easily secured to and detached from theframe4 using afirst closure strap14 and asecond closure strap16. Thefirst closure strap14 and thesecond closure strap16 are able to secure thecover12 in place in a position above thesole assembly6.
• Thefirst closure strap14 and thesecond closure strap16 may be fastening belts or bands that extend across the face of theremovable cover12, opposite theframe4 andsole assembly6, and thus exert a downward force on theremovable cover12 towards theframe4 andsole assembly6. Thefirst closure strap14 and thesecond closure16 are oriented on opposite ends of the removable cover12 (such that thefirst closure strap14 is near the patient's ankle and thesecond closure strap16 is near the patient's toes, for example). Thefirst closure strap14 and thesecond closure strap16 may be laces for tying, or may include self-engaging hook and loops. Thefirst closure strap14 and thesecond closure strap16 may be fully adjustable, so that theremovable cover12 may be adjusted with respect to theframe4 andsole assembly6.
• Thefirst closure strap14 and thesecond closure strap16 are secured to theframe4 by one ormore fixation elements18. The embodiment shown inFIG. 2 shows one fixation element for each strap. That is,fixation element18 is secured to theframe4 and receives one of thefirst closure strap14 or thesecond closure strap16. The structure and attachment offixation element18 to theframe4 is discussed in more detail below.
• Once theremovable cover12 is secured to theframe4, a cavity is defined between themidsole portion8 of thesole assembly6 and theremovable cover12 for housing and protecting a foot. As shown inFIG. 1, the cavity includes anankle opening20 in a rear area of the medical shoe2 (i.e. near the patient's ankle), aforefoot opening22 opposite theankle opening20 in a front area of the medical shoe2 (i.e. near the patient's toes), and amidfoot opening24 in between theankle opening20 and the forefoot opening22 in a central area of the medical shoe2. These openings, particularly theforefoot opening22 and themidfoot opening24, allow the patient or another person, such as a medical professional, to access the protected foot without removing the medical shoe2.
• The cavity may be configured to receive a foot after theremovable cover12 is secured to theframe4. In the alternative, theremovable cover12 may be configured to be secured to theframe4 after a foot has been received into themidsole8.
• FIG. 3 is a side elevation view of a frame according to an aspect of an exemplary embodiment.
• Theframe4 includes aframe lip26, a frame lip heel portion28, and aframe web portion30. Theframe web portion30 is a planar surface of theframe4 that is parallel or substantially parallel with themidsole portion8 of thesole assembly6 when thesole assembly6 is inserted into theframe4. Theframe lip26 extends around the edge of theframe web portion30 in a direction perpendicular to theframe web portion30, so as to define an outer perimeter of the foot bed and/or to create a wall around the medical shoe2. For instance, theframe web portion30 extends in a horizontal plane, while theframe lip26 extends in a vertical plane around theframe web portion30.
• The frame lip heel portion28 is an extended portion of theframe lip26 adjacent to a rear heel area of themidsole portion8 below theankle opening20 of the assembled medical shoe2. For instance, the frame lip heel portion28 defines a back wall for supporting the patient's heel and extends further from theframe web portion30 than the remainder of theframe lip26. Thus, the frame lip heel portion28 may provide added support to a rear area of the patient's foot or ankle when the patient's foot is inserted into the medical shoe2.
• Theframe lip26 includesfixation projections32 and34 that allowfixation elements18, for example, of the medical shoe2 to be secured to theframe4. Thefixation projections32 and34 extend from theframe lip26 in a substantially horizontal direction parallel or substantially parallel with theframe web portion30.Rear fixation projections32 are located on both sides of a rear area of theframe lip26, i.e., on opposing sides of the frame lip heel portion28. Therear fixation projections32 are provided on the frame lip heel portion28 and thus are displaced further from theframe web portion30 in a vertical direction thanfront fixation projections34.Front fixation projections34 are located on both sides of a front area of theframe lip26. Thus,fixation projections32 and34 are located on opposing sides of theframe4 at both the rear and front areas, for a total of four fixation projections extending from theframe4. However, any number of fixation projections may be provided, and thefixation projections32 and34 may be located at any position on theframe4.
• Theframe lip26 may include one ormore holes36,37, and38 formed therein. As shown inFIG. 3, the frame lip heel portion28 includes two side ventilation holes36 and acenter ventilation hole37. Thecenter ventilation hole37 is centrally located in the frame lip heel portion28 and corresponds to the rear or back side of theframe4. The side ventilation holes36 are symmetrically provided on either side of thecenter ventilation hole37.
• Theframe4 further includes side projection holes38 formed in theframe lip26 that are used to secure other elements toframe4. As shown inFIG. 3, side projection holes38 are provided in theframe lip26 on opposite sides of the front area of theframe4. However, the side projection holes38 may be provided at any location of theframe lip26, including the central area of theframe lip26 and the rear area of theframe lip26.
• Theframe4 further includes a plurality of throughholes40,41,42,43,44,45, and46 formed in theframe web portion30. For instance, a heel projection throughhole40 is formed in a rear portion of theframe web portion30 adjacent to the frame lip heel portion28. The heel projection throughhole40 may be larger than the other throughholes41,42,43,44,45, and46 and is centrally located in the rear area of theframe web portion30. Midfoot projection throughholes41,42,43, and44 are formed in a central portion of theframe web portion30 between the rear area and the front area of theframe web portion30 and may be smaller than the heel projection throughhole40. Midfoot projection thoughholes41 and43 are formed in theframe web portion30 on a first side of a central axis of theframe web portion30, and midfoot projection throughholes42 and44 are formed in theframe web portion30 on a second side of the central axis of theframe web portion30. Forefoot projection throughholes45 and46 are formed in a front area of theframe web portion30 on each side of the central axis. The projection through holes may be symmetrically oriented such that projection throughholes41,43, and45 are mirror images of projection throughholes42,44, and46 with respect to the central axis of theweb portion30.
• Theframe4 may be made of any light weight rigid material such that theframe4 provides a form shaping exoskeleton for the medical shoe2. For instance, theframe4 may be made of a thermoplastic including polyethylene, polypropylene, polystyrene and polyvinyl chloride. The frame may also be made by a thermoset polymer including polyurethane.
• FIGS. 4A, 4B, and 4C are bottom, side, and side elevation views of a sole assembly according to an aspect of an exemplary embodiment.
• Thesole assembly6 includes themidsole portion8 on the top side of thesole assembly6 and theoutsole portion10 on the bottom of thesole assembly6. The midsole portion defines the foot bed configured to receive the patient's foot and to be positioned within theframe4 in the medical shoe2 once assembled. Theoutsole portion10 is configured to form the ground contacting surface of the medical shoe2 and is configured to extend from theframe4. Thesole assembly6 defines a rear heel area configured to receive the patient's heel and positioned adjacent to theankle opening20 when the medical shoe2 is assembled. Thesole assembly6 further includes a front forefoot area configured to receive the patients forefoot positioned adjacent to theforefoot opening22 when the medical shoe2 is assembled. Thesole assembly6 also includes a midfoot area configured to receive the patient's midfoot positioned adjacent to themidfoot opening24 when the medical shoe2 is assembled.
• Themidsole portion8 includes a planarfoot supporting portion52 and a midsole lip48 circumferentially provided around the edge of thefoot supporting portion52. The midsole lip48 extends in a direction substantially perpendicular to thefoot supporting portion52 so as to create a wall around the edge of thefoot supporting portion52. As shown inFIG. 4C, the midsole lip48 may create a square forefoot design to act as a bumper to protect the patient's forefoot and to provide a better universal left/right fit.
• The midsole lip48 includes amidsole lip rib49 and a midsolelip heel portion50. Themidsole lip rib49 is a rib or raised band extending around the top edge of the midsole lip48. Themidsole lip rib49 may assist in positioning or seating thesole assembly6 into theframe4. For instance, themidsole lip rib49 may be positioned so as to act as a bumper or stopper and to stop thesole assembly6 from being inserted farther into theframe4 once thesole assembly6 is properly seated in theframe4. When thesole assembly6 is inserted into theframe4, the midsole lip rib may come into contact with the frame lip28, indicating that thesole assembly6 is properly seated in theframe4.
• The midsole lip48 further includes the midsolelip heel portion50 at the rear area of themidsole portion8. The midsolelip heel portion50 extends further away from thefoot supporting portion52 than the remainder of the midsole lip48, thus defining a heightened back wall for the patient's heel. The midsolelip heel portion50 may provide additional support to the patient's heel and ankle when the patient's foot is inserted into thesole assembly6.
• Thefoot supporting portion52 is generally or substantially planar, and is shaped to receive and support the patient's foot. In other words, although thefoot supporting portion52 is generally flat and extends along a horizontal plane, thefoot supporting portion52 may be curved to correspond to certain contours of the patient's foot. The curvature may include a raised portion in midfoot area of thefoot supporting portion52, for instance to provide additional support to the arches of the patient's foot. The front forefoot area of thefoot supporting portion52 may also include an upward curvature for supporting the patient's forefoot. In the alternative, thefoot supporting portion52 may be flat so as to receive a removable insole.
• The midsole lip48 may include a plurality of ventilation holes54 and55 formed in the midsole lip48 that provide ventilation to the patient's foot.Side ventilation portions54 are formed on either side ofcenter ventilation portion55 in the midsolelip heel portion50 of the midsole lip48. For instance, when thesole assembly6 is inserted into theframe4, theventilation portions54 and55 in thesole assembly6 are aligned with the ventilation holes36 and in theframe lip26. Thus, when assembled, the medical shoe2 has uninterrupted ventilation holes providing a ventilating current of air to the patient's foot.
• Fixation projections56 are provided on opposing sides on the front area of the midsole lip48. Thefixation projections56 extend from the midsole lip48 in a direction substantially perpendicular to the midsole lip48, i.e., parallel to thefoot supporting portion52. As shown inFIG. 4, twofixation projections56 are provided in the front area of themidsole portion8. However, any number offixation projections56 may be provided, and they may be positioned at any position along the midsole lip48.
• Theoutsole portion10 includes a plurality ofprojections58,59,60,61,62,63, and64 extending outwardly from the bottom of thefoot supporting portion52. Theprojections58,59,60,61,62,63, and64 may extend in a direction perpendicular or at an angle to thefoot supporting portion52, and the projections may all extend at the same angle or at different angles. A bottom or lower exterior surface of theprojections58,59,60,61,62,63, and64 form the ground contacting surface of thesole assembly6.
• The plurality ofprojections58,59,60,61,62,63, and64 include aheel projection58, fourmidfoot projections59,60,61, and62, and twoforefoot projections63 and64. Theheel projection58 extends from the rear area of thefoot support portion52 adjacent to the midsolelip heel portion50 and corresponds to the heel of the patient's foot. Theheel projection58 may be larger relative to the remainder of theprojections59,60,61,62,63, and64, and is centrally provided on the rear area of thefoot supporting portion52.
• The midfoot andforefoot projections59,60,61,62,63, and64 are located on either side of a central axis bisecting thefoot supporting portion52. For instance,projections59,61, and63 are located on a first side of the central axis of the foot supporting portion52 (i.e., a right side of the patient's foot), while theprojections60,62, and are located on a second side of the central axis of thefoot supporting portion52 opposite the first side (i.e., a left side of the patient's foot). More so, as shown inFIG. 4A, adjacent projections may be symmetric such that the entire configuration of theoutsole portion10 is symmetric with respect to the central axis. For instance, midfoot projection is symmetric in shape tomidfoot projection60,midfoot projection61 is symmetric in shape tomidfoot projection62, andforefoot projection63 is symmetric in shape to forefootprojection64. Further,heel projection58 may have a symmetric shape about the central axis. However, the shape and size of the projections may vary, and the possible configurations are not limited to those illustrated herein.
• While theheel projection58 and themidfoot projections59,60,61, and62 are substantially perpendicular to thefoot support portion52, theforefoot projections63 and64 may be provided at an angle to thefoot supporting portion52, as shown inFIG. 4B. For example, thefoot supporting portion52 may be substantially planar, and theforefoot projections63 and64 may be provided at an angle to thefoot supporting portion52 so as to point in a forward walking direction. Alternatively, thefoot supporting portion52 may have a curvature, and theforefoot projections63 and may point in the same forward walking direction while remaining perpendicular to thefoot supporting portion52. By configuring theforefoot projections63 and64 at an angle to a walking surface, additional support may be provided to the patient, for instance when walking or stepping.
• The symmetry of theoutsole portion10 as shown inFIG. 4A offers significant therapeutic benefits to the medical shoe2. For example, each of theheel projection58, therear midfoot projections59 and60, thefront midfoot projections61 and62, and theforefoot projections63 and64 correspond to a particular area of the foot, i.e., the heel, the rear midfoot, the front midfoot, and the forefoot area, respectively. Each of the heel, the rear midfoot, the front midfoot, and the forefoot area of the foot may therefore be isolated and treated individually via the corresponding projections. That is, theprojections58,59,60,61,62,63, and64 may be designed to isolate particular regions of the foot, and may treat each region of the foot depending on a desired off-loading scenario. In other words, each of theprojections58,59,60,61,62,63, and64 can be designed and/or modified to address a desired weight distribution across the patient's heel, rear midfoot, front midfoot, and forefoot depending on a condition of the patient's heel, rear midfoot, front midfoot, and forefoot. Two such off-loading scenarios are described inFIGS. 8-9 (discussed below).
• Each of theprojections58,59,60,61,62,63, and may include an indentation ordepression65 that circumscribes the projection adjacent to the interface with thefoot supporting portion52. Theindentation65 may be continuously formed around the entire circumference of each of the projections, and may assist in securing thesole assembly6 to theframe4 by receiving and securing an adjacent portion of theframe web portion30 into theindentation65. That is, theframe web portion30 presses into theindentation65 around the circumference of each of the projections to secure theframe4 to thesole assembly6.
• In use, thesole assembly6 is inserted into theframe4 such that thesole assembly6 is received into and seated in theframe4.Projections58,59,60,61,62,63, and64 correspond to projection throughholes40,41,42,43,44,45, and46, respectively, and are pushed through to extend from theframe4 through the projection throughholes40,41,42,43,44,45, and46. In other words, when thesole assembly6 is properly inserted into theframe4, theheel projection58 is pushed through and extends from the heel projection throughhole40,midfoot projections59,60,61, and62 are pushed through and extend from the midfoot projection throughholes41,42,43, and44, respectively, and theforefoot projections63 and64 are pushed through and extend from the forefoot projection throughholes45 and46, respectively.
• When the projections are inserted into and pushed through the respective projection through holes in theframe4, thesole assembly6 and theframe4 are secured to each other by a frictional force, i.e., secured with a snap-fit without gluing or stitching. For example, the midsole lip48 and theframe lip26 are configured to have corresponding contours such that when thesole assembly6 is inserted into theframe4, a snap fit is established. The contours of theframe lip26 may mirror the contours of the midsole lip48 such that theframe lip26 receives and secures thesole assembly6 to theframe4.
• The frictional force between thesole assembly6 and theframe4 may be aided by various features, for instance thefixation projections56 extending from thesole assembly6. When thesole assembly6 is inserted into theframe4, thefixation projections56 are received into the side projection holes38, ensuring a secure seating of thesole assembly6 in theframe4. Also, theventilation portions54 and55 may include ribs circumscribing theventilation portions54 and55 (FIG. 4C) in thesole assembly6 that may be received into the ventilation holes36 and37 to further seat thesole assembly6 in theframe4. Finally, theindentations65 circumscribing the base of each of theprojections58,59,60,61,62,63, and64 may receive an adjacent portion of theframe web portion30 when thesole assembly6 is fully inserted into theframe4. Thus, theindentations65 are configured to receive and lock theframe4 in a position where theprojections58,59,60,61,62,63, and64 are fully extended through the projection throughholes40,41,42,43,44,45, and46.
• According to an aspect of an exemplary embodiment, thesole assembly6 may be a patient specific sole assembly. In this case, the sole assembly may be designed according to a specific patient's needs or based off data received from a patient. The data may include foot data, including the size, shape, and/or curvature of the patient's foot. In this case, themidsole portion8 of thesole assembly6 may be tailored to the size and curvature of the patient's foot. The foot data may include an image scan, a CT scan, and MRI scan, a mold, or a combination thereof.
• The data may also include patient data, i.e., information about a condition of the patient, for instance whether the patient has experienced one or more of surgery of the foot, trauma of the foot, a wound of the foot, or an ulceration of the foot. In this case, the projections may be designed based on the condition of the patient to achieve a therapeutic weight distribution across the patient's foot. The patient data may include data from medical records, data received from a medical database, or data received from a medical professional.
• In the alternative, thesole assembly6 may not be patient specific, and instead may be made without consideration of data from a specific patient. In this case, the midsole portion may be provided in varying sizes, and the patient may be provided with asole assembly6 that most closely matches the size of the patient's foot.
• Theframe4 may or may not be patient specific depending on the structure of thesole assembly6. It is contemplated that theframe4 is designed to be interchangeable with the various configurations of thesole assembly6. For instance, even if asole assembly6 is specially designed to accommodate a larger foot, i.e., by increasing the size of the foot bed, thesole assembly6 may still be designed to be received into theframe4 having a standardized size.
• Thesole assembly6 may be made of Ethylene-vinyl acetate (EVA), or any other material that is “rubber-like” in softness and flexibility. EVA may also be referred to as expanded rubber or foam rubber. Themidsole portion8 andoutsole portion10 are integrally molded and formed with one mold.
• FIGS. 5A and 5B are front and back perspective views of a fixation element according to an aspect of an exemplary embodiment.
• Thefixation element18 includes an exterior portion defining an outside edge of thefixation element18, a projection throughhole68, a closure strap throughhole70, and aninterior portion72. The projection throughhole68 is a hole configured to receive one of thefixation projections32 and34 extending from theframe4. Theinterior portion72 is a tooth or projection that borders the projection throughhole68 and defines an edge of the projection throughhole68. Thefixation elements18 are secured to theframe4 by inserting one of thefixation projections32 and34 into the projection throughhole68 of thefixation element18. Theinterior portion72 comes into contact with thefixation projection32 or34 and locks thefixation element18 into place. Either of thefirst closure strap14 and thesecond closure strap16 may be threaded through the closure strap throughhole70 for securing thecover12 to thefixation elements18, and thus to theframe4. When assembled, afixation element18 may be secured to each of thefixation projections32 and34 extending from theframe4.
• FIG. 6 is a side elevation view of a cover according to an aspect of an exemplary embodiment.
• Typically, shoes include an upper stitched or otherwise permanently attached to the outsole of the shoe. However, the medical shoe2 disclosed herein does not require an upper, and instead may have aremovable cover12 that is configured to secure the medical shoe2 to the patient's foot. Theremovable cover12 allows for easy access to the patient's foot, is easily removable and permits easy insertion of the patient's foot into the medical shoe, and eliminates the buckle pressure of traditional shoe securing elements. Thecover12 may be configured to substantially match the contours of the top of the patient's foot, and may include a first closure strap throughhole74 and a second closure strap throughhole76. Thecover12 is secured to theframe4 via thefirst closure strap14, thesecond closure strap16, the first closure strap throughhole74, and the second closure strap throughhole76. For instance, the first14 and second16 closure straps are threaded through the first74 and second76 closure strap through holes, and are secured to a closure strap throughhole70 in acorresponding fixation element18.
• Thecover12 may further include various impressions and indentations in the surface of thecover12 for added functionality. For instance, thecover12 further includes aventilation portion78 comprising holes formed in the body of thecover12 in between the first74 and second76 closure strap through holes. Thus, when the patient's foot is inserted in the assembled medical shoe2, the ventilation portion provides ventilating air to the foot of the patient.
• Thecover12 may also include depressions formed on the surface of thecover12 for receiving and positioning the closure straps14 and16. For instance, a first closurestrap receiving portion80 and a second closurestrap receiving portion82 for positioning the first14 and second16 closure straps are provided on the surface of thecover12. When thefirst closure strap14 is threaded into the first closure strap throughhole74, thefirst closure strap14 is received into the first closurestrap receiving portion80 so that thefirst closure strap14 does not slide out of position on the face of thecover12. Similarly, when thesecond closure strap16 is threaded into the first closure strap throughhole76, thesecond closure strap16 is received into the second closurestrap receiving portion82 so that thesecond closure strap16 is secured in place with respect to thecover12. Thecover12 may also include acover nameplate84 for placing advertisements, trademarks, logos, or the like.
• In use, thecover12 is easily separable from the medical shoe2 using the first14 and second16 closure straps. For instance, the first14 and second16 closure straps can be unfastened, and thecover12 can be removed by pulling thecover12 straight up in a direction away from thesole assembly6. Thisremovable cover12 provides multiple advantages, for example, the ability to secure thecover12 to theframe4 after the patient's foot has been received into thesole assembly6. In the alternative, thecover12 may be secured to theframe4 prior to the patient's foot being received into thesole assembly6.
• FIG. 7 is a side perspective view of a liner according to an exemplary embodiment.
• Aliner86 may be optionally inserted into the cavity of the medical shoe2. Theliner86 includes anankle portion88, aforefoot portion90, afoot supporting portion92, and abody portion94. Theliner86 may be inserted into the medical shoe2 such that theforefoot portion90 corresponds to theforefoot opening22, theankle portion88 corresponds to theankle opening20, thebody portion94 corresponds to themidfoot opening24, and thefoot supporting portion92 corresponds to thefoot supporting portion52. Theliner86 may be inserted into the medical shoe2 before or after theremovable cover12 is secured to theframe4 via the first14 and second16 closure straps.
• Theliner86 may further include anankle portion rib96 around a circumference of theankle portion88 to ensure proper seating of theliner86 in the medical shoe2. For instance, when theliner86 is inserted into the medical shoe2, theankle portion rib96 may abut an edge of theankle opening20 when theliner86 is properly seated in the medical shoe2.
• FIG. 8 is a side perspective view of a medical shoe having a modified outsole heel projection according to an aspect of an exemplary embodiment.
• Depending on the patient's medical condition, it may be desirable to off-load pressure from the patient's heel by shifting weight to the midfoot and forefoot areas, for instance to promote faster healing after surgery, trauma, or when wounds or ulcerations are present on the heel.FIG. 8 is an example of a medical shoe2 for off-loading weight from the patient's heel and shifting the weight to the midfoot and forefoot areas of the patient's foot. Such an off-loading configuration may be desirable in cases of rear foot trauma, wounds or ulcerations present on the heel area, and post-surgical healing for either soft tissue or bony structure of the heel.
• The medical shoe2 shown inFIG. 8 includes a modifiedheel projection98. The modifiedheel projection98 is modified to be shorter than the remainder of the outsole projections such that the weight of the patient is off-loaded from the heel area of the patient's foot and is distributed across the remaining projections corresponding to the patient's midfoot and forefoot areas.
• One or more of the projections may optionally includeside contouring104, as illustrated inFIG. 8. Also, the ground contacting surface of each of the projections may be either of a low tractionground contact surface106, or a high tractionground contacting tread108. Theground contacting tread108 may have increased traction over theground contacting surface106, and thus may be used to create zones of increased traction under each of the projections when increased traction is required.
• FIG. 9 is a side perspective view of a medical shoe having modified midfoot and forefoot projections according to an aspect of an exemplary embodiment.
• In some instances, it may be desirable to reduce weight bearing pressure on the patient's forefoot to promote faster healing after surgery, trauma, or when forefoot wounds or ulcerations are present. Thus,FIG. 9 is an example of a medical shoe2 for off-loading weight from the patient's forefoot and shifting the weight to the midfoot and heel area.
• The medical shoe2 includes modifiedforefoot projections101 and102 that are shorter than the remaining outsole projections.Midfoot projections99 and100 are also modified to include a scalloped or ridged shape, so as to direct weight-bearing pressure away from a front section of the midfoot area.
• According to an aspect of an exemplary embodiment, the benefit of the medical shoes ofFIGS. 8-9 may be achieved without requiring outsole projections of varying lengths, e.g., wherein each of the outsole projections has the same or a uniform length, as shown inFIG. 1. For example, different offloading scenarios may be achieved by constructing theoutsole assembly6 including theoutsole portion10 of materials having varying densities. By utilizing multi-density materials, for example multi-density EVA foam, area specific pressure reduction can be achieved by strategic placement of low-density materials and high-density materials.
• As an example, the benefit of the medical shoe2 ofFIG. 8 can be achieved using asole assembly6 including projections58-64 having the same or a uniform length, as shown inFIG. 1. Rather than providing the modifiedoutsole heel projection98 ofFIG. 8, theoutsole heel projection58 may be constructed of a low-density material, i.e., a material having a lower density than the remaining outsole projections59-64, such as a relatively lower density EVA foam. With theoutsole heel projection58 being constructed of a lower density material than the remaining outsole projections59-64, the weight of the patient is off-loaded from the heel area of the patient's foot and is distributed across the remaining projections corresponding to the patient's midfoot and forefoot areas.
• Similarly, the benefit of the medical shoe2 ofFIG. 9 can be achieved by constructing theforefoot projections63 and64 out of a low-density material, i.e., a material having a lower density than the remaining outsole projections58-62, such as a relatively lower density EVA foam. With theforefoot projections63 and64 being constructed of a lower density material than the remaining outsole projections58-62, the weight of the patient is off-loaded from the forefoot area of the patient's foot and is distributed across the remaining projections corresponding to the patient's midfoot and heel areas.
• According to another aspect of an exemplary embodiments, each of the projections58-64 may have an independently determined density so as to create a customized off-loading scenario, for example, designed for a specific patient. That is, each of the projections58-64 may have the same or a different density, and the densities of each of the projections58-64 may be determined individually so as to create a customized off-loading scenario based on a particular desired off-loading effect. By decreasing the relative density of each projection58-64, a greater off-loading effect may be achieved with respect to the adjacent portion of the patient's foot.
• FIGS. 10A and 10B are front and back perspective views of a removable insole according to an aspect of an exemplary embodiment.
• Theremovable insole110 includes a midsoleportion facing side112 and afoot receiving side114. Theremovable insole110 is configured to be inserted into the medical shoe such that the midsoleportion facing side112 faces themidsole portion8 of thesole assembly6, and more specifically thefoot supporting portion52, and such that thefoot receiving side114 faces up towards thecover12 in order to receive and support the patient's foot.
• Theremovable insole112 further includes pressure distribution pegs116 on the midsoleportion facing side112 that provide customizable targeted off-loading of the patient's foot. By adjusting the relative lengths of the pressure distribution pegs116, weight may be off-loaded from targeted areas of the patient's foot. For instance, pressure distribution pegs116 adjacent to an injured area of the patient's foot may be made shorter than pressure distribution pegs116 adjacent to non-injured areas of the patient's foot. Thus, weight can be off-loaded from the injured area of the patient's foot to the non-injured areas of the patient's foot.
• FIG. 11 is a side perspective view of an ankle liner according to an aspect of an exemplary embodiment.
• Similar to the removable insole ofFIGS. 10A and 10B, anankle liner118 may be used for targeted off-loading of the patient's foot and ankle. Theankle liner118 includes anankle portion120, aheel portion122, and afoot portion124. Theankle liner118 is configured to be inserted into the medical shoe2, and to provide support to the ankle, heel and foot areas of the patient. Thus, theankle liner118 extends from the patient's ankle to the patient's forefoot.
• Theankle liner118 also includes the pressure distribution pegs116 to provide customizable targeted off-loading from patient's ankle, heel, midfoot, and forefoot. By adjusting the relative lengths of the pressure distribution pegs116, weight may be off-loaded from targeted areas of the patient's ankle and foot.
• Theankle liner118 further includes ventilation holes126 for providing ventilated air to areas of the patient's ankle and foot. Thus, even when the patient's foot is received into the assembled medical shoe, ventilating air may be provided through the ventilation holes in theankle liner118.
• FIGS. 12A and 12B are front and back perspective views of a removable toe cover according to an aspect of an exemplary embodiment.FIG. 13 is a side perspective view of a medical shoe having a removable toe protector according to an aspect of an exemplary embodiment.
• The medical device2 may include adetachable toe protector128 for use when the patient has a wound or other trauma to the toes or front forefoot area. For example, thedetachable toe protector128 may protect the patient's toes and front forefoot area from foreign objects that may agitate or worsen the traumatized region while promoting easy visual inspection thereof.
• The toe protector includes two elongated portions, i.e., ananterior portion130 and adorsal portion132. Theanterior portion130 extends from a central area of thedorsal portion132 in a direction substantially perpendicular to thedorsal portion132, so as to form a protective guard. Theanterior portion130 and thedorsal portion132 may also be curved so as to form a cup shape.
• Thetoe protector128 may includefixation elements134 and136 for detachably fixing the toe protector to the medical shoe2. The fixation elements may include a nub or protrusion extending from a surface of thetoe protector128. However, the exemplary embodiments are not limited thereto, and any fixation element known to provide a detachable connection may be provided, including snaps, magnetic connectors, or the like. Ananterior fixation element134 may be located at an end of theanterior portion130 opposite the side that theanterior portion130 is joined to thedorsal portion132. Thedorsal portion132 may includedorsal fixation elements136 on both ends thereof.
• Thetoe protector128 may include holes in the body thereof for promoting easy visual inspection of, as well as for providing a circulating air current to, the patient's toe and front forefoot region. For example, thetoe protector128 may include ananterior hole138 centrally located in theanterior portion130. Thetoe protector128 may further include adorsal center hole140 centrally located in thedorsal portion132. Thedorsal center hole140 may be surrounded on either side by dorsal side holes142.
• When fixed to the medical shoe2, as shown inFIG. 13, thetoe protector138 may be received into thesole assembly6 via thefixation elements134 and136 so as to form a protective guard above theforefoot opening22. For instance, thesole assembly6 may include a receiving portions (not shown) for receiving thefixation elements134 and136 and fixing thetoe protector128 to thesole assembly6. The receiving portions may include corresponding holes, snaps, or magnetic connectors corresponding to thefixation elements134 and136.
• Thedorsal portion132 may be positioned across the medical shoe2 in a direction perpendicular to the patient's foot, i.e., parallel to thefirst closure strap14 and thesecond closure strap16. Theanterior portion130 may be positioned to extend from thedorsal portion132 in a direction parallel to the patient's foot, i.e., perpendicular to the first closure strap and the second closure strap. In this configuration, thetoe protector128 substantially fills and protects the patient's foot in the area of theforefoot opening22. Additionally, theanterior portion130 bisects the forefoot opening into a first forefoot opening22aand a second forefoot opening22b, such that easy visual inspection is maintained.
• Thetoe protector128 may be made of the same material as thesole assembly6, for instance, EVA foam, or may be made of a different material suitable for providing protection to the foot. Thetoe protector128 is preferably made of a rigid material that is also lightweight and flexible for promoting the patient's comfort, including plastic, polystyrene, expanded polystyrene (EPS), lightweight metals, fiberglass, and the like.
• While one or more exemplary embodiments have been described with reference to the figures, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope as defined by the following claims.

Claims (20)

What is claimed is:

1. A medical shoe comprising:

a sole assembly configured to support a foot, the sole assembly comprising:

a midsole portion forming a substantially planar surface for supporting the foot; and

an outsole portion comprising a plurality of outsole projections extending from the midsole portion; and

a frame surrounding the sole assembly, the frame comprising a plurality of through holes corresponding to the plurality of outsole projections,

wherein the plurality of outsole projections extend through the plurality of through holes in the frame so as to form a ground contacting surface,

wherein the plurality of outsole projections are provided in a symmetrical pattern, and

wherein the sole assembly is secured to the frame by a self-locking fit between the sole assembly and the frame.

2. The medical shoe ofclaim 1, wherein:

the sole assembly further comprises a sole assembly lip portion extending around a circumferential edge of the sole assembly in a direction perpendicular to the substantially planar surface,

the frame further comprises a frame lip portion surrounding the sole assembly lip portion such that a contour of an inner surface the frame lip portion corresponds to a contour of an outer surface the sole assembly lip portion, and

the self-locking fit comprises a frictional force between the sole assembly and the frame.

3. The medical shoe ofclaim 2, wherein:

the sole assembly further comprises a fixation projection extending from the sole assembly lip portion in a direction parallel to the substantially planar surface,

the frame further comprises a fixation projection through hole in the frame lip portion, and

the fixation projection extends into the fixation projection through hole.

4. The medical shoe ofclaim 1, wherein:

the midsole portion comprises a rear heel portion, a midfoot portion, and a front forefoot portion; and

the plurality of outsole projections comprises:

a plurality of outsole forefoot projections extending from the front forefoot portion;

a plurality of outsole midfoot projections extending from the midfoot portion, and

an outsole heel projection extending from the rear heel portion.

5. The medical shoe ofclaim 4, wherein a thickness of at least one of the plurality of outsole midfoot projections is greater than a thickness of the outsole heel projection.

6. The medical shoe ofclaim 4, wherein a thickness of at least one of the plurality of outsole midfoot projections is greater than a thickness of at least one of the plurality of outsole forefoot projections.

7. The medical shoe ofclaim 4, wherein the sole assembly is composed of ethylene-vinyl acetate.

8. The medical shoe ofclaim 4, wherein the plurality of outsole projections have a non-uniform density.

9. The medical shoe ofclaim 1, further comprising a removable cover secured to the frame and located above the sole assembly, such that a cavity configured to surround the foot is defined by a bottom surface of the removable cover and a top surface of the sole assembly.

10. The medical shoe ofclaim 9, further comprising a fixation element and a closure strap, wherein:

the fixation element is secured to a fixation projection extending from the frame and comprises a fixation element slot configured to receive the closure strap;

the removable cover comprises a removable cover slot configured to receive the closure strap, and

the closure strap is positioned through the fixation element slot and through the removable cover slot.

11. The medical shoe ofclaim 9, further comprising ventilation holes formed in the removable cover.

12. The medical shoe ofclaim 1, further comprising a removable insole located on the substantially planar surface, the removable insole comprising:

a foot supporting portion; and

a plurality of pressure distribution pegs extending from the food supporting portion towards the substantially planar surface,

wherein the plurality of pressure distribution pegs are non-uniform in height.

13. A snap fit medical shoe assembly, comprising

a sole assembly configured to support a foot, the sole assembly comprising:

a midsole portion forming a substantially planar surface for supporting the foot;

an outsole portion comprising a plurality of outsole projections extending from the midsole portion; and

a sole assembly lip portion extending around a circumferential edge of the sole assembly in a direction perpendicular to the substantially planar surface;

a rigid exoskeleton configured to surround the sole assembly, the rigid exoskeleton comprising a plurality of through holes corresponding to the plurality of outsole projections and an exoskeleton lip portion corresponding to the sole assembly lip portion; and

a removable cover configured to be secured to the rigid exoskeleton,

wherein the plurality of outsole projections are configured to extend through the plurality of through holes in the rigid exoskeleton so as to form a ground contacting surface, and

wherein a contour of an inner surface the exoskeleton lip portion corresponds to a contour of an outer surface the sole assembly lip portion, such that the sole assembly is configured to be secured to the rigid exoskeleton by a snap fit between the sole assembly and the rigid exoskeleton.

14. The snap fit medical shoe assembly ofclaim 13, wherein:

the midsole portion comprises a rear heel portion, a midfoot portion, and a front forefoot portion;

the plurality of outsole projections comprises a pair of outsole midfoot projections extending from the midfoot portion, and only one of:

an outsole heel projection extending from the rear heel portion; or

a pair of outsole forefoot projections extending from the front forefoot portion; and

the plurality of outsole projections are provided in a symmetrical pattern.

15. The snap fit medical shoe assembly ofclaim 14, wherein the plurality of outsole projections comprises the pair of outsole forefoot projections extending from the front forefoot portion, and wherein the pair of outsole forefoot projections are provided at an angle with respect to the substantially planar surface.

16. The snap fit medical shoe assembly ofclaim 14, wherein the plurality of outsole projections comprises a total of 7 outsole projections.

17. A method of attaching orthopedic bracing, the method comprising:

providing a sole assembly configured to support a foot of a patient, the sole assembly comprising:

a midsole portion forming a substantially planar surface for supporting the foot; and

an outsole portion comprising a plurality of outsole projections extending from the midsole portion,

wherein the plurality of outsole projections are provided in a symmetrical pattern;

providing a rigid exoskeleton, the rigid exoskeleton comprising a plurality of through holes corresponding to the plurality of outsole projections;

positioning the sole assembly into an interior of the rigid exoskeleton such that the plurality of outsole projections extend through the plurality of through holes in the rigid exoskeleton, the plurality of outsole projections forming a ground contacting surface, such that the sole assembly is secured to the rigid exoskeleton by a snap fit between the sole assembly and the rigid exoskeleton;

positioning the substantially planar surface adjacent to a bottom portion of the foot of the patient; and

positioning a removable cover adjacent to a top portion of the foot of the patient foot and securing the removable cover to the rigid exoskeleton.

18. The method ofclaim 17, wherein the providing the sole assembly comprises providing a sole assembly based on data of the foot of the patient, such that the plurality of outsole projections are oriented according to a medical condition of the patient.

19. The method ofclaim 18, wherein the providing the rigid exoskeleton comprises providing a rigid exoskeleton not based on the data of the foot of the patient.

20. The method ofclaim 18, wherein the medical condition of the patient is one from among: surgery of the foot, trauma of the foot, a wound of the foot, and an ulceration of the foot.

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